165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP.

00:00 Introduction and Welcome

00:26 Meet Marta: CEO of Radius Research

00:58 Understanding Target Product Profiles (TPPs)

01:44 The Importance of TPPs in Drug Development

01:59 Defining a TPP

03:22 TPP as a Strategic Document

05:28 TPP in Preclinical and Clinical Stages

07:09 Challenges and Misconceptions in TPP Development

14:27 Regulatory Considerations for TPPs

14:53 Sections of a TPP

39:07 Understanding Toxicology Evaluations

39:34 FDA Requirements for Pre-IND Talks

39:51 TPP and Toxicity Thresholds

41:41 Go/No-Go Criteria in TPP

42:50 PKPD and Drug Distribution

45:40 Drug Formulation and Quality Attributes

46:36 Regulatory Strategy and 505(b)(2) Pathway

52:34 Differentiation and Risk Assessment

01:03:42 Transition from Discovery to Development

01:07:48 Combination Products and Delivery Systems

01:09:35 Conclusion and Contact Information

Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. She can be reached at mnew@radyusresearch.com